Duns Number:198227881
Device Description: 68NSDP VSM6800 UDI BASE MODEL
Catalog Number
68NSDP
Brand Name
Welch Allyn, Inc.
Version/Model Number
901060
Device Commercial Distribution Status
In Commercial Distribution
Commercial Distribution End Date
-
Issuing Agency
In GS1
MRI safety Status
Labeling does not contain MRI Safety Information
Device required to be labeled as containing natural rubber latex or dry natural rubber (21 CFR 801.437)
-
Device labeled as "Not made with natural rubber latex"
-
For Single-Use
-
Prescription Use (Rx)
Yes
Over the Counter (OTC)
-
Kit
-
Combination Product
-
Human Cell, Tissue or Cellular or Tissue-Based Product (HCT/P)
-
FDA Premarket Submission
-
Product Code
MWI
Product Code Name
Monitor, physiological, patient (without arrhythmia detection or alarms)
Public Device Record Key
ef33f5c7-7d2b-4c2c-b333-49c6d43b1342
Public Version Date
June 27, 2022
Public Version Number
4
DI Record Publish Date
December 22, 2020
Package DI Number
00732094252187
Quantity per Package
1
Contains DI Package
00732094345308
Package Discontinue Date
-
Package Status
In Commercial Distribution
Package Type
-
| Device Class | Device Class Description | No of Devices |
|---|---|---|
| 1 | A medical device with low to moderate risk that requires general controls | 374 |
| 2 | A medical device with a moderate to high risk that requires special controls. | 4080 |
| 3 | A medical device with high risk that requires premarket approval | 1 |